Medical devices for therapeutic heat treatments

ABSTRACT

An expandable balloon catheter having an elongate shaft having a distal end region and an expandable balloon coupled to the distal end region of the elongate shaft is disclosed. One or more cutting members are attached to the expandable balloon, wherein at least a portion of each of the one or more cutting members comprises a Curie material having a Curie temperature between 60° and 400° Celsius.

CROSS-REFERENCE TO RELATED APPLICATIONS

The following commonly assigned patent applications are incorporatedherein by reference, each in its entirety:

U.S. Pat. App. Ser. No. 61/980,995 (Sutermeister et al.), entitledDEVICES AND METHODS FOR THERAPEUTIC HEAT TREATMENT, filed on Apr. 17,2104.

U.S. Pat. App. Ser. No. 61/980,952 (Sutermeister et al.), entitledMEDICAL DEVICES FOR THERAPEUTIC HEAT TREATMENTS, filed on Apr. 17, 2014;and

U.S. Pat. App. Ser. No. 61/981,003 (Sutermeister et al.), entitledCOMPOSITIONS FOR THERAPEUTIC HEAT DELIVERY, filed on Apr. 17, 2014 and

U.S. Pat. App. Ser. No. 61/980,936 (Sutermeister et al.), entitledDEVICES AND METHODS FOR THERAPEUTIC HEAT TREATMENT, filed on Apr. 17,2104.

TECHNICAL FIELD

The present disclosure pertains to medical devices, systems, and methodsfor using the medical devices. More particularly, the present disclosurepertains to medical devices that can provide a therapeutic treatmentusing heat.

BACKGROUND

Therapeutic heat treatment can be used to treat a wide variety ofmedical conditions such as tumors, fungal growth, etc. Heat treatmentscan be used for treating medical conditions alongside other therapeuticapproaches or as a standalone therapy. Heat treatment provides localizedheating and thus lacks any cumulative toxicity in contrast to othertreatment methods such as drug-based therapy, for example.

Known heat treatments, however, suffer from certain drawbacks. Forexample, using known treatments, it can be difficult to control theamount of heat delivered to a target area, which can cause undesireddamage. Also, known treatment methods can be less focused, leading todamage of surrounding healthy tissue.

Therefore, a need remains to develop devices and methods for providinghomogeneous and more controlled therapeutic heat treatments.

SUMMARY

In at least one embodiment, a topical product comprises a base emulsionand a plurality of nanoparticles. Desirably, the nanoparticles arehomogeneously distributed within the base emulsion to comprise at least2% of the product by weight. The nanoparticles have a Curie temperaturebetween 37° and 60° Celsius.

In at least one embodiment, a medical device coating comprises apolymeric base and a plurality of nanoparticles. The nanoparticles arehomogeneously distributed within the polymeric base and comprise lessthan 10% of the coating by weight. The nanoparticles have a Curietemperature between 37° and 140° Celsius.

In at least one embodiment, an expandable balloon catheter has anelongate shaft including a distal end region and an expandable ballooncoupled to the distal end region of the elongate shaft. One or morecutting members are attached to the expandable balloon, wherein at leasta portion of each of the one or more cutting members comprises a Curiematerial having a Curie temperature between 60° and 400° Celsius.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of the invention is hereafter described withspecific reference being made to the drawings.

FIG. 1 is a perspective view of a body surface that is being treatedwith an embodiment of a topical product.

FIG. 2 is a perspective view of a coated medical device.

FIG. 3 is a partial view of an embodiment of an embodiment of acoagulation device.

FIG. 3A is a cross-sectional view of the embodiment of FIG. 3.

FIG. 4 illustrates a method of treating a tumor using the coagulationdevice of FIGS. 3 and 3A.

FIG. 5 a side view of a portion of another illustrative coagulationdevice.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe scope of the disclosure.

DETAILED DESCRIPTION

Definitions are provided for the following defined terms. It is intendedthat these definitions be applied, unless the context indicatesotherwise.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used herein, the singular forms “a”, “an”, and “the” include pluralreferences unless the context clearly evidences or indicates otherwise.As used herein, the term “or” is generally employed in its senseincluding “and/or” unless the context clearly evidences or indicatesotherwise.

References herein to “an embodiment,” “some embodiments,” “otherembodiments,” etc., indicate that an embodiment includes a particularfeature, structure, or characteristic, but not every embodimentnecessarily includes the particular feature, structure, orcharacteristic. Moreover, such phrases do not necessarily refer to thesame embodiment. Further, when a particular feature, structure, orcharacteristic is described in connection with an embodiment (or moreembodiments), it should be understood that such feature, structure, orcharacteristic may also be used in connection with other embodiments,whether or not explicitly described, unless clearly evidenced or statedto the contrary.

“Curie temperature” is defined as the temperature at which permanentmagnetic properties of a material convert into induced magneticproperties, or vice versa.

“Curie materials” refer to those metals or metal alloys that exhibitmagnetic properties based on selected Curie temperatures. Curietemperature of a Curie material may be altered by using compositematerials, which may or may not be ferromagnetic. Changes in doping,additives, composites, alloying, size, and density of Curie materialscan alter the structure and behavior of the Curie material and alter theCurie temperature.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of thedisclosure.

FIG. 1 is a perspective view depicting a body surface 100 with a topicalproduct 102 applied to it. In some embodiments, the body surface 100 mayinclude any external or internal surface of a patient such as skin,fingernail, toenail, mucus membranes, etc. As illustrated, the topicalproduct 102 is applied to a treatment area 101 on the body surface 100,for example to treat a skin disease such as fungal infection, or thelike. The topical product 102, which may be formulated as creams, foams,gels, lotions, ointments, or other suitable formulations, in turn,provides a therapeutic heat treatment to the treatment area 101, asdiscussed in greater detail below.

In some embodiments, the topical product 102 includes a base emulsion104 and plurality of nanoparticles 106. For simplicity, a singlenanoparticle 106 is labeled in the drawings, however, it should beunderstood that the topical product 102 may comprise any suitable numberof nanoparticles 106 such as two, four, six, eight, twenty, forty, onehundred, one thousand, more than one thousand, or any numbertherebetween. In some embodiments, the percentage of nanoparticles 106in the base emulsion 104 (e.g., by weight percent) may depend on avariety of factors, for example: (1) the type of treatment, (2) theamount of heat required for treatment, (3) the type of body surface 100,etc. In some embodiments, the nanoparticles 106 comprise at least 2% ofthe topical product 102 by weight. In some embodiments, however, thenanoparticles 106 comprise at least 3% of the topical product 102 byweight. Other suitable percentages of the nanoparticles 106 in thetopical product 102 may include at least 4%, 5%, 8%, 15%, or more, byweight. It should be noted that any other suitable percentage of thenanoparticles 106 may also be contemplated, without departing from thescope of the present disclosure.

In some embodiments, the nanoparticles 106 are homogeneously distributedwithin the base emulsion 104. The homogenous distribution of thenanoparticles 106 in the base emulsion 104 may be used to achieve ahomogeneous mixture forming the topical product 102. The homogeneousdistribution of the product 102 may provide ease of application on thetreatment area 101. However, this is not required.

In some embodiments, the base emulsion 104 is an oil-based orwater-based emulsion. In some embodiments, the base emulsion 104includes petroleum jelly and/or polyethylene glycol.

In some embodiments, the nanoparticles 106 are made from Curie materialshaving magnetic properties. Under influence of a desired electric ormagnetic field, the nanoparticles 106 deliver heat therapy to the bodysurface 100 (e.g., skin, nails, etc.). In some embodiments, thenanoparticles 106 are heated to their Curie temperature. In particular,in some embodiments, the magnetic nanoparticles 106 are subjected to analternating field. Upon application of the alternating field, themagnetic nanoparticles 106 begin to heat. Generally, at temperaturesless than the Curie temperature (T<T_(c)), the magnetic nanoparticles106 (and/or compositions thereof) are ferro- (or ferri-) magnetic andtransition into paramagnetic phase upon reaching the Curie temperature(T_(c)). Also upon reaching the Curie temperature, however, an appliedAC field no longer induces a temperature rise due to the loss ofmagnetic susceptibility at the Curie temperature. Thus, the temperatureof the nanoparticles 106 is stabilized to within a small temperaturerange at or near the predetermined Curie temperature.

Further, the heating of the topical product 102 may be controlled bycontrolling intensity, frequency, or other related parameters of theelectro-magnetic field applied to the topical product 102 or morespecifically to the magnetic nanoparticles 106. Once the temperature ofnanoparticles 106 reaches its Curie temperature, heating stops, avoidingany unwanted damage to the treatment area 101.

In some embodiments, the magnetic nanoparticles 106 have a compositionsuch that the Curie temperature (T_(c)) is in the range between about37° Celsius to about 60° Celsius. In some embodiments, the Curietemperature is in the range between about 40° Celsius to about 50°Celsius. And, in some embodiments, the Curie temperature is 43° Celsiusto about 48° Celsius, for example.

Therapeutic heat treatments in one or more embodiments may be performedusing magnetic nanoparticles 106 having Curie temperatures between about37° Celsius to about 60° Celsius. Such nanoparticles 106 are configuredto treat the body surface 102, such as skin and/or nails, withoutcausing inadvertent damage to the non-target body regions. In someembodiments, the Curie material may include GaMnN (gallium manganesenitride) and/or ZnO (zinc oxide) or other materials. Other examples ofsuitable materials include Manganese Arsenide having a Curie temperatureabout 45° Celsius.

The topical product 102 can be used to treat a wide variety of ailments.For example, the topical product 102 may be used to treat warts,lesions, parasitic infections, skin cancer, or the like. In someembodiments, the treatment area 101 is an area with a fungal infectionbeneath a finger nail and the treatment area is to be heated at atemperature ranging between about 40° Celsius to about 60° Celsius inorder to disrupt fungal growth. In some embodiments, the topical product102 is in the form of a nail polish that can be applied to the nail bythe patient in their home. Upon application of the topical product 102to the nail surface, it can be used to disrupt fungal grown underneaththe nail upon application of a suitable electric or magnetic field. Thetarget temperature for heat treatment may be in the range of about 37°Celsius to about 60° Celsius.

In some embodiments, the topical product 102 is applied to a mucousmembrane of the patient to treat a variety of diseases. For instance,the topical product 102 may be applied to the mucosal wall of trachea orother regions of the respiratory tract such as bronchus, nasal cavity,bronchioles, etc. In some embodiments, the product 102 is used as amucolytic agent to heat treat excess mucous production. Further, in someembodiments, the topical product is employed to treat one or more othersymptoms of airway related diseases such as chronic pulmonaryobstructive disease (COPD).

In some embodiments, the nanoparticles 106 include a therapeutic drug.Such drug may be selected to treat a particular ailment. For example,drugs, including anti-fungal agents such as salicylic acid, polyenes,imidazoles, triazoles, thiazoles, etc. may be incorporated. Thoseskilled in the art may select the appropriate one or more drugs for aparticular patient or ailment. In some embodiments, the drug is releasedas disclosed in the co-filed application entitled, “DEVICES AND METHODSFOR THERAPEUTIC HEAT TREATMENT”, U.S. Pat. App. Ser. No. 61/980,936(Sutermeister et al.), filed on Apr. 17, 2014, which is hereinincorporated by reference. Additionally, the contents of the co-filedapplication entitled, “COMPOSITIONS FOR THERAPEUTIC HEAT DELIVERY”, U.S.Pat. App. Ser. No. 61/981,003 (Sutermeister et al.), also filed on Apr.17, 2014, are herein incorporated by reference.

One or more medical devices may also incorporate Curie nanoparticles fordelivering therapeutic heat treatment. For example, FIG. 2 shows amedical device 200 coated with Curie nanoparticles in accordance with anembodiment of the present disclosure. In some embodiments, the medicaldevice 200 includes an elongated member 202 having a coating 204 appliedon its outer surface 205. In some embodiments, the elongated member 202comprises an inflatable medical balloon. However the elongated member202 can further comprise any other suitable device adapted to beintroduced inside a patient's body such as, but not limited to a stent,inflatable medical balloon, catheter, basket, or the like. The coating204 may be applied to a portion of the outer surface 205 of theelongated member 202 or over the entire outer surface of the elongatedmember 202. In some embodiments, the elongated member 202 has a distalend region 201 and a proximal end region 203.

In some embodiments, the elongated member 202 has a long, thin, flexibletubular structure. A person skilled in the art will appreciate thatother suitable structures exist such as, but not limited to,rectangular, oval, irregular, or the like. In some embodiments, theelongated member 202 is sized and configured to accommodate passagethrough the intravascular path, which leads from a percutaneous accesssite in, for example, the femoral, brachial, or radial artery, to atargeted treatment site. In other embodiments, the elongated member 202may be sized and configured to pass through other portions of theanatomy, such as, but not limited to, the respiratory system,gastrointestinal, urological, gynecological, etc.

In some embodiments, the medical device coating 204 includes a polymericbase 206 and a plurality of magnetic nanoparticles 208. In an example,the nanoparticles 208 are mixed with the polymeric base 206 to create ahomogenous mixture. Those skilled in the art will appreciate that anysuitable method may be employed to combine the polymeric base 206 andthe nanoparticles 208 to form the coating 204, for example, conventionalmethods such as encapsulation. Once formed, the coating 204 may beapplied to the medical device 200 by various methods such as spraying,painting, etching, etc. The coating 204 may be applied to a variety ofmedical devices, including, but not limited to a stent, inflatablemedical balloon, catheter, basket, cutting members, such as cuttingmembers 512 described below, coagulation elements, such as coagulationelements 306 described below, or the like

The polymeric base 206 may comprise a suitable polymer such aspolyurethane, styrene isobutylene styrene, or other polymers known tothe art. In some embodiments, the polymeric base 206 comprises one ormore biodegradable polymers, which may be designed to degrade within thebody. Suitable examples include Polylactides (PLA), Polyglycolides(PGA), Poly(lactide-co-glycolides) (PLGA), Polyanhydrides,Polyorthoesters, Polycyanoacrylates, Polycaprolactone, or the like. Insome embodiments, these degradable polymers are broken down intobiologically acceptable molecules to be metabolized and removed from thebody via normal metabolic pathways.

In some embodiments, the nanoparticles 208 comprise magneticnanoparticles having a selected Curie temperature. In some embodiments,the magnetic nanoparticles 208 have Curie temperatures falling in therange between about 37° Celsius to about 140° Celsius. However, itshould be noted that any suitable Curie material having a suitable Curietemperature may also be used in the coating 206, which may be dictatedby the temperature range required to heat and/or treat a body tissue orregion.

In some embodiments, the magnetic nanoparticles 208 may comprise lessthan 10% of the coating 204 by weight. The nanoparticles 208 maycomprise any suitable percentage in the coating 204 such as, but notlimited to, 4%, 8%, 12%, 24%, 48%, or more. The percentage of thenanoparticles 208 may vary depending on various factors, for example—a)the amount of heat required for the therapy, and b) the Curietemperature of the magnetic nanoparticles 208 used to form the coating204.

In some embodiments, the medical device 200 is navigated through apatient's body to reach a treatment region. In some instances, themedical device 200 is an inflatable medical balloon having a coating 204disposed on its outer surface 205. Upon reaching the treatment region,the medical device 200 is inflated using a conventional inflationmechanism (e.g., inflation fluid such as saline) such that the coating204, in particular the nanoparticles 208, come into contact with thesurrounding body tissue. Further, inflation of the balloon allows thenanoparticles 208 to come in close proximity with a desired treatmentarea. At this point, a suitable electric or magnetic external field maybe applied, allowing the magnetic nanoparticles 208 to heat.Alternatively, or additionally, the electric or magnetic field may beapplied from within the medical device 200, as will be described in moredetail with respect to FIG. 5. Once the temperature of the magneticnanoparticles 208 reaches its Curie temperature, the nanoparticles 208stop heating until the temperature again falls below the Curietemperature.

Some embodiments may be used to treat varicose veins. Such veins maybecome enlarged and/or tortuous due to one or more pathologicalconditions. For treatment purposes, the medical device 200 having aballoon-shaped structure may be employed. In some embodiments, theballoon has the coating 204 applied to its outer surface. The balloonmay be used to constrict or occlude the varicose vein by heating it atabout 120° Celsius, for example. To accomplish this, in someembodiments, the balloon is inserted within the patient's body to reacha target area just adjacent to or inside the varicose vein. Once thetarget area is reached, RF energy or a magnetic field is applied from anexternal or internal source, for example, heating the magneticnanoparticles 208 disposed in the coating 204. The heat may thus occludethe varicose vein. In such an example, the magnetic nanoparticles 208may have a Curie temperature of about 120° Celsius.

Further, in some embodiments, the medical device 200 is used for nervetreatment for denervation of renal artery, carotid sinus, splanchnicnerves, bronchial nerves, pulmonary artery denervation, etc.Furthermore, the device 200 may be used for tissue ablation, painmitigation, muscle pacing or relaxation, etc.

In some embodiments, the nanoparticles 208 include two different typesof nanoparticles, each type having its own Curie temperature. In someembodiments, the nanoparticles having a lower Curie temperature have ahigher concentration than the nanoparticles having a higher Curietemperature. Such an arrangement permits the medical device 200 to havetwo Curie temperatures. In this way, using a lower power alternatingcurrent field, for example, the temperature can be raised to the Curietemperature of the first type of nanoparticles. Using a higher power ACfield, for example, the temperature can be raised to the second, higher,Curie temperature, which is associated with the second type ofnanoparticles. In some embodiments, the first type of nanoparticles hasa Curie temperature of 40 degrees Celsius and the second type ofnanoparticles has a Curie temperature of 60 degrees Celsius. Anembodiment of a medical device 200 utilizing two such types ofnanoparticles may comprise a polymeric implant which is deformed at thelower Curie temperature and it is heat-set upon reaching the higherCurie temperature, thereby fixing the shape of the polymeric implant.Another embodiment utilizing two such types of nanoparticles mayidentify the medical device 200 at the first Curie temperature viamagnetic resonance; and, the medical device 200 can then be raised tothe second Curie temperature once the position within the patient's bodyis as intended. For example, a lumen or bodily structure can be ablatedat the second Curie temperature.

It will be appreciated that nanoparticles having a third Curietemperature can also be included in yet another concentration, forexample. Each of the two or more types of nanoparticles can thusly takeon a different functionality, such as drug release and drug destruction,imaging and ablation, deformation (e.g., weakening) and heat shapesetting.

FIGS. 3 and 3A depict partial and cross-sectional views, respectively,of a coagulation or cutting device 360. In some embodiments, thecoagulation device 360 comprises a medical balloon 300, which is adaptedto be introduced inside a patient's body, in a similar way as themedical device 200 of FIG. 2.

In some embodiments, the coagulation device 360 is employed to cut,cauterize, and/or coagulate the surrounding body tissue, upon reaching atreatment region within the patient's body. For instance, thecoagulation device 360 may be employed to cut the tumor 402 (FIG. 4),cauterize a tissue such as to occlude and/or seal a vessel (e.g., arteryor vein), or cut a lesion or stenosis. In some embodiments, thecoagulation device 360 (e.g., medical balloon 300) includes a centralregion 302, a thermal insulator 304, and a coagulation element 306,which, in some embodiments is a cutting member. In some embodiments,however, the thermal insulator 304 is not required. In some instances,the thermal insulator 304 may also function as a bonding pad configuredto attach the coagulation element 306 to the balloon 300.

In some embodiments, the central region 302 forms the body of themedical balloon 300. In the illustrated embodiment, the central region302 has a substantially tubular geometry with circular cross-section.Those skilled in the art will appreciate that the central region 302 mayhave any suitable cross-sectional shape such as, but not limited to,rectangular, oval, irregular, or the like, however. In some embodiments,the thermal insulator 304 is attached to at least a portion of thecentral region 302. According to one or more embodiments, the thermalinsulator 304 includes a pad, chip, layer, or other suitable structurecapable of being attached to at least a portion of the central region302. In the illustrated embodiment, the thermal insulator 304 has apad-shaped structure, which may be attached to an outer surface 301 ofthe central region 302. Some embodiments employ an adhesive to attachthe thermal insulator 304 to the central region 302. The thermalinsulator 304 and/or coagulation element 306 can also be attached via anadhesive pad, glue, mechanical coupling, injection molded thermopolymeror thermoset pad, overmolding of the coagulation element 306, via acomposite pad having a polymer or urethane and a ceramic or otherthermo-insulating material, or other suitable mechanism to attach thestructures, such as a dovetail or keyway slide-in lock ortongue-in-groove. In some embodiments, a polymeric adhesive pad isemployed to attach the thermal insulator 304 to the central region 302.Such an adhesive pad may be thermally insulating and thus may be madefrom a suitable material. For example, an adhesive pad may be made ofpolyolefin, PET, polyimide, silicone, refractory ceramic fiber, or thelike.

In some embodiments, the coagulation device 360 includes coagulationelement 306, which may be attached to the thermal insulator. In someembodiments, the coagulation device 360 may include a plurality ofcoagulation elements 306. For example, the coagulation device 360 mayinclude three cutting members 306, which may be attached to the threethermal insulators 304 at three portions of the central region 302 ofthe medical balloon 300, for example. The coagulation device 360 (e.g.,medical balloon 300) may comprise any suitable number of coagulationelements 306 (e.g., cutting members) such as one, two, four, six, ormore.

In some embodiments, the coagulation element 306 has a substantiallytriangular shape having a sharp edge and/or tip 309. Some embodimentsmay include other suitable shapes of the coagulation element 306 such asrectangular, or the like.

In one or more embodiments, the coagulation element 306 includes a bladehaving a base 307 and a tip 309, where the base 307 is attached to thethermal insulator 304 and the tip 309 is adapted to cut body tissue. Insome embodiments, the base 307 of the coagulation element 306 is madefrom ceramic or stainless steel. The coagulation element 306 may be madefrom any suitable material capable of coagulating and/or cutting thesurrounding tissue. In some embodiments, such material should berelatively rigid and sharp. Suitable examples include ceramic, metal,bi-metal, or bi-material. Further, in some embodiments, the tip 309comprises at least one Curie material or element 311. To this end, insome embodiments, the tip 309 is made of a Curie material or the tip 309may have a coating of Curie material, for example coating 204. SuchCurie material may include MnBi, MnSb, CrO₂, MnOFe₂O₂, Nickel, or thelike, either in combination or alone. Those skilled in the art willappreciate that any other suitable Curie material and/or element mayalso be employed. When the coagulation device is suitably deployedadjacent to the desired treatment region, a suitable electric ormagnetic external field may be applied, allowing the Curie material 311to heat. Alternatively, or additionally, the electric or magnetic fieldmay be applied from within the coagulation device 360, as will bedescribed in more detail with respect to FIG. 5. Once the temperature ofthe Curie material 311 reaches its Curie temperature, the Curie material311 stops heating until the temperature again falls below the Curietemperature.

Also, in some embodiments, the coagulation device 360 (e.g., medicalballoon 300) includes a circulatory system 313, as shown in FIG. 4,which may be adapted to cool the coagulation device 360 during theprocedure. The circulation system 313 may be configured to continuouslyor intermittently exchange the inflation fluid (or other fluid) withinthe balloon 300 for a cool fluid from, for example, a reservoirconfigured to remain outside the body. In some instances, the fluid maybe provided at room temperature or chilled to a temperature lower thanroom temperature. Such a circulation system 313 may prevent damage ofthe coagulation device 360 as well the surrounding normal tissue (tissuenot requiring treatment) from the heat of the coagulation element 306.Circulatory systems include a fluid such as cooled saline, contrast,cryogenic system, etc. In some embodiments, the circulatory system isemployed to inflate and/or deflate the medical balloon 300.

FIG. 4 illustrates a method of treating a tumor 402 using a coagulationdevice 360 in the form of the medical balloon 300. According to themethod, the medical balloon 300 is advanced through a patient's body toreach a body vessel 404. The medical balloon 300 may be advanced throughthe body using an introduction device such as delivery sheath orcatheter (not explicitly shown). In some embodiments, an operator (e.g.,a physician, clinician, etc.) retracts a portion of the catheter oncethe medical balloon 300 is disposed within the body vessel 404. Withinthe vessel 404, the medical balloon 300 is manipulated such that atleast one coagulation element 306 is generally aligned with the tumor402. The balloon 300 may be expanded such that the coagulation elementcomes in close proximity to the tumor 402. In some instances, expansionof the balloon 300 may also expand the body vessel 404. Subsequently, anexternal field 406 (e.g., magnetic field) may be provided to activatethe Curie element 311 of the coagulation element 306. Alternatively, oradditionally, the electric or magnetic field may be applied from withinthe coagulation device 360, as will be described in more detail withrespect to FIG. 5. Once activated, the curie element 311 begins to heat,which may be employed by the coagulation element 306 to cut and or treatthe tumor 402.

In some embodiments, the Curie element 311 has a Curie temperature inthe range between about 60° Celsius to about 400° Celsius and, in someembodiments, between 100° Celsius to about 400°. A temperature in theseranges may be used to successfully treat the tumor. During theprocedure, in some embodiments, the medical balloon 300 is rotated bythe operator through its proximal end. The rotating medical balloon 300may be beneficial as, in some embodiments, the sharp coagulation element306 provides mechanical cutting through its sharp tip 309. In someembodiments, however, the medical balloon 300 is not rotated during theprocedure.

In addition to treating tumors, the coagulation device 360 may be usedfor tissue ablation to treat cysts, endometriomas, cancers,pre-cancerous cells, warts, lesions, endovascular canalization,annulation, endovascular incision for graft, interstitial fluid drainage(e.g., lymph), bacterial infection fluid release, general angioplasty,atherectomy, plaque scoring, vulnerable plaque ablation, arterialdebulking, calcified disease scoring, crack initiation or propagation,etc. Other applications may include RF cutting at a controlledtemperature, treatment of hemorrhoids, purposeful scarring of tissue ofthe cervix or sphincter bulking through scarring of the esophagus orurethra. Further, although shown in the context of medical balloon 300,the coagulation element 306 can be used on or with a surgical tool,surgical blade, needle, cut/coagulation tool, or in any other suitablemedical device.

Further, in some embodiments, the coagulation device(s) 360, such asmedical balloon 300, are coated with Curie materials via UltrasonicDispersing equipment. For example, a dispersion of polyurethane inMethyl Ethyl Ketone (MEK) in a solution of 0.5-0.65% Corethane 50Dpolyurethane, 1.0-10.0% dimethylacetamide, and balance tetrahydrofurancan be employed. Alternatively, styrene isobutylene styrene (SIBS) intoluene may be used in lieu of MEK. In some embodiments, a solution ofthe polymer is prepared in a solvent and is added to 10% by weight ofthe nanoparticles (NP) of Curie materials. To keep the Curienanoparticles well dispensed throughout the spraying process, anultrasonic spray system, for example, SonicSyringe, CSP Flow andSonoFlow CSP from Sono-Tek can be employed. The balloon or other tubulardevices may be sprayed using such equipment by rotating the balloon inthe ultrasonic spray plume. In some embodiments, the sprayed balloon isthen subjected to infrared (IR) drying to speed the process of coatingthe balloon with Curie materials or nanoparticles.

FIG. 5 illustrates a side view of another illustrative medical device300 in partial cross-section. The medical device 500 may include anelongate member or catheter shaft 502, an expandable member or balloon504 coupled to a distal end region 522 of the shaft 502, and anelectromagnetic coil 506 disposed around the distal end region 522 ofthe elongate shaft 502 and within an interior portion of the balloon504. Additional electromagnetic coils 506 may also be utilized eitherwithin the device 500 or at a location configured to be external to apatient's body. The electromagnetic coil 506 may be in electricalcommunication with a power and control unit configured to remain outsidethe body. The power and control unit may supply an electrical current tothe coil 506 to generate a magnetic field. It is contemplated that theelectrical current supplied to the coil 506 and/or the size of the coil506 may be varied to generate the desired magnetic field. When in use,the balloon 504 may be filled with an inflation fluid such as saline toexpand the balloon 504 from a collapsed configuration to an expandedconfiguration. The inflation fluid may be introduced through a fluidinlet 508 and evacuated through a fluid outlet 510. This may allow thefluid to be circulated within balloon 504.

In some embodiments, the device 500 may include one or more coagulationelements or cutting members 512 coupled to the balloon 504. The cuttingmembers 512 may vary in number, position, and arrangement about theballoon 504. For example, the device 500 may include one, two, three,four, five, six, or more cutting members 512 that are disposed at anyposition along balloon 504 and in a regular, irregular, or any othersuitable pattern.

In one or more embodiments, the cutting member 512 includes a bladehaving a base 514 and a tip 516. The cutting member 512 may be securedor attached to the balloon 504 through a pad 520. In some embodiments,the pad 520 may be a thermal insulator or include materials havinginsulating properties. For example, the pad 520 may be similar in formand function to the thermal insulator 304 described above. In someembodiments, the base 514 of the cutting member 512 is made from ceramicor stainless steel, although this is not required. The cutting member512 may be made from any suitable material capable of coagulating and/orcutting the surrounding tissue. In some embodiments, the material shouldbe relatively rigid and sharp. The tip 516 may comprise at least oneCurie material or element 518. For example, the tip 516 may be made of aCurie material or the tip 516 may have a coating of Curie materialsimilar to the coating 204 described above. Alternatively, the cuttingmember 512 may be formed entirely of a Curie material. Such Curiematerials may include MnBi, MnSb, CrO₂, MnOFe₂O₂, nickel, or the like,either in combination or alone. Those skilled in the art will appreciatethat any other suitable Curie material and/or element may also beemployed.

The medical device 500 may be advanced through a patient's body to reacha target treatment region. The medical device 500 may be advancedthrough the body using an introduction device such as delivery sheath orcatheter (not explicitly shown). In some embodiments, an operator (e.g.,a physician, clinician, etc.) retracts a portion of the catheter oncethe medical device 500 is disposed within or adjacent to the targettreatment region. Within the target treatment region, the medical device500 may be manipulated such that at least one cutting member 512 isgenerally aligned with the target treatment region. The balloon 504 maybe expanded such that the cutting member 512 comes in close proximity tothe target treatment region. Subsequently, an electric or magnetic fieldmay be applied from within the balloon 504 via coil 506. It iscontemplated that placing the electromagnetic coil 506 in closeproximity the Cure material 518 may allow for the use of weaker orsmaller magnetic fields. Once activated, the Curie material 518 beginsto heat, which may be employed by the cutting member to cut and or treatthe target treatment region. Once the temperature of the Curie material518 reaches its Curie temperature, the Curie material 518 stops heatinguntil the temperature again falls below the Curie temperature.

In some embodiments, the Curie material 518 has a Curie temperature inthe range between about 60° Celsius to about 400° Celsius and, in someembodiments, between 100° Celsius to about 400°. A temperature in theseranges may be used to successfully treat the tumor. During theprocedure, in some embodiments, the medical device 500 is rotated by theoperator through its proximal end. The rotating medical device 500 mayprovide mechanical cutting with the cutting member 512 through its sharptip 516. In some embodiments, however, the medical device 500 is notrotated during the procedure.

The following documents are incorporated herein by reference, each inits entirety:

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A description of some embodiments of the heat treatments is contained inone or more of the following numbered statements:

Statement 1

A coagulation device comprising:

a central region;

a thermal insulator attached to at least a portion of the centralregion; and

a coagulation element attached to the thermal insulator, at least aportion of the coagulation element formed from a Curie material having aCurie temperature between 60° and 400° Celsius.

Statement 2

The coagulation device of statement 1, wherein the coagulation elementis configured as a cutting member.

Statement 3

The coagulation device of any one of the preceding statements, whereinthe Curie material has a Curie temperature between 100° and 400°Celsius.

Statement 4

The coagulation device of any one of the preceding statements, whereinthe Curie material is selected from the group consisting of MnBi, MnSb,CrO₂, MnOFe₂O₂, Nickel, and combinations thereof.

Statement 5

The coagulation device of any one of the preceding statements, whereinthe coagulation element has a coating, the coating comprising the Curiematerial.

Statement 6

The coagulation device of statement 5, wherein the coating includes apolymeric base and a plurality of nanoparticles.

Statement 7

The coagulation device of statement 6, wherein the nanoparticlescomprise less than 10% of the coating by weight.

Statement 8

The coagulation device of any one of the preceding statements, whereinthe coagulation element defines a base and a tip, the tip comprising theCurie material.

Statement 9

The coagulation device of statement 8, wherein the base of thecoagulation element is ceramic or stainless steel.

Statement 10

The coagulation device of any one of the preceding statements furthercomprising an adhesive pad disposed between the thermal insulator andthe central region, the adhesive pad attaching the thermal insulator tothe central region.

Statement 11

The coagulation device of any one of the preceding statements furthercomprising a circulatory system, the circulator system configured tocool the coagulation device.

Statement 12

The coagulation device of statement 2, wherein the cutting membercomprises at least three cutting members.

Statement 13

The coagulation device of any one of the preceding statements, whereinthe thermal insulator is adhesively attached to the at least a portionof the central region.

Statement 14

The coagulation device of any one of the preceding statements, whereinthe coagulation device comprises a medical balloon.

Statement 15

The coagulation device of statement 14, wherein medical balloon hasthree thermal insulators, each of the thermal insulators having acutting member attached thereto.

Statement 16

A topical product comprising:

a base emulsion; and

a plurality of nanoparticles homogeneously distributed within the baseemulsion, the nanoparticles having a Curie temperature between 37° and60° Celsius, wherein the nanoparticles comprise at least 2% of theproduct by weight.

Statement 17

The topical product of statement 16, wherein the nanoparticles compriseat least 3% of the product by weight.

Statement 18

The topical product of statement 17, wherein the nanoparticles compriseat least 5% of the product by weight.

Statement 19

The topical product of statement 18, wherein the nanoparticles compriseless than 15% of the product by weight.

Statement 20

The topical product of statement 18, wherein the nanoparticles compriseless than 8% of the product by weight.

Statement 21

A medical device coating comprising:

a polymeric base; and

a plurality of nanoparticles homogeneously distributed within thepolymeric base, the nanoparticles having a Curie temperature between 37°and 140° Celsius, wherein the nanoparticles comprise less than 10% ofthe coating by weight.

Statement 22

The medical device coating of statement 21 in combination with a stent.

Statement 23

The medical device coating of statement 21 in combination with aninflatable medical balloon.

Statement 24

The medical device coating of statement 21 in combination with acatheter.

Statement 25

The medical device coating of statement 21, wherein the polymeric baseincludes polyurethane.

Statement 26

The medical device coating of statement 21, wherein the polymeric baseincludes styrene isobutylene styrene.

Statement 27

A coagulation device comprising:

a central region;

a thermal insulator attached to at least a portion of the centralregion; and

a coagulation element attached to the thermal insulator, at least aportion of the coagulation element formed from a Curie material having aCurie temperature between 100° and 400° Celsius.

Statement 28

The coagulation device of statement 27, wherein the Curie material isselected from the group consisting of MnBi, MnSb, CrO₂, MnOFe₂O₂,Nickel, and combinations thereof.

Statement 29

The coagulation device of statement 27, wherein the coagulation elementhas a coating, the coating comprising the Curie material.

Statement 30

The coagulation device of statement 27, wherein the coagulation elementdefines a base and a tip, the tip comprising the Curie material.

Statement 31

The coagulation device of statement 30, wherein the base of thecoagulation element is selected from the group consisting of ceramic orstainless steel.

Statement 32

The coagulation device of statement 27 further comprising an adhesivepad disposed between the thermal insulator and the central region, theadhesive pad attaching the thermal insulator to the central region.

Statement 33

The coagulation device of statement 32, wherein the adhesive pad ispolymeric.

Statement 34

The coagulation device of statement 27 further comprising a circulatorysystem, the circulator system configured to cool the coagulation device.

Statement 35

The coagulation device of statement 27, wherein the coagulation elementcomprises at least three cutting members.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. An expandable balloon catheter comprising: anelongate shaft having a distal end region; an expandable balloon coupledto the distal end region of the elongate shaft; and one or more cuttingmembers attached to the expandable balloon, wherein at least a portionof each of the one or more cutting members comprises a Curie materialhaving a Curie temperature between 60° and 400° Celsius.
 2. Theexpandable balloon catheter of claim 1, further comprising anelectromagnetic coil disposed around the distal end region of theelongate shaft and within an interior portion of the expandable balloon.3. The expandable balloon catheter of claim 2, further comprising apower and control unit in electrical communication with theelectromagnetic coil.
 4. The expandable balloon catheter of claim 1,wherein the at least a portion of the one or more cutting memberscomprising the Curie material is formed from the Curie material.
 5. Theexpandable balloon catheter of claim 1, wherein the at least a portionof the one or more cutting members comprising the Curie materialcomprises a coating of the Curie material.
 6. The expandable ballooncatheter of claim 5, wherein the coating includes a polymeric base and aplurality of magnetic nanoparticles.
 7. The expandable balloon catheterof claim 6, wherein the magnetic nanoparticles comprise less than 10% ofthe coating by weight.
 8. The expandable balloon catheter of claim 1,wherein the Curie material has a Curie temperature between 100° and 400°Celsius.
 9. The expandable balloon catheter of claim 1, wherein theCurie material is selected from the group consisting of MnBi, MnSb,CrO₂, MnOFe₂O₂, Nickel, and combinations thereof.
 10. The expandableballoon catheter of claim 1, wherein the one or more cutting memberseach define a base and a tip, the tip comprising the Curie material. 11.The expandable balloon catheter of claim 10, wherein the base of the oneor more cutting members is ceramic or stainless steel.
 12. Theexpandable balloon catheter of claim 1, further comprising an adhesivepad disposed between each of the one or more cutting members and theexpandable balloon.
 13. The expandable balloon catheter of claim 1,further comprising a fluid circulation system, the fluid circulationsystem configured to cool the coagulation device.
 14. The expandableballoon catheter of claim 1, wherein the one or more cutting memberscomprises at least three cutting members.
 15. The expandable ballooncatheter of claim 1, further comprising a thermal insulator disposedbetween each of the one or more cutting members and the expandableballoon.
 16. An expandable balloon catheter comprising: an elongateshaft having a distal end region; an expandable balloon coupled to thedistal end region of the elongate shaft; and at least one cutting memberattached to the expandable balloon, wherein the at least one cuttingmember comprises a base and a tip, the tip formed from a Curie materialhaving a Curie temperature between 60° and 400° Celsius; a thermallyinsulating pad member disposed between the at least one cutting memberand the expandable balloon; and an electromagnetic coil disposed aroundthe distal end region of the elongate shaft and within an interiorportion of the expandable balloon.
 17. The expandable balloon catheterof claim 16, wherein the Curie material is selected from the groupconsisting of MnBi, MnSb, CrO₂, MnOFe₂O₂, Nickel, and combinationsthereof.
 18. An expandable balloon catheter comprising: an elongateshaft having a distal end region; an expandable balloon coupled to thedistal end region of the elongate shaft; and at least one cutting memberattached to the expandable balloon, wherein the at least one cuttingmember comprises a base and a tip, the tip coated with a Curie materialhaving a Curie temperature between 60° and 400° Celsius; a thermallyinsulating pad member disposed between the at least one cutting memberand the expandable balloon; and an electromagnetic coil disposed aroundthe distal end region of the elongate shaft and within an interiorportion of the expandable balloon.
 19. The expandable balloon catheterof claim 18, wherein the Curie material is selected from the groupconsisting of MnBi, MnSb, CrO₂, MnOFe₂O₂, Nickel, and combinationsthereof.
 20. The expandable balloon catheter of claim 18, wherein thecoating comprises a polymeric base and a plurality of magneticnanoparticles.